NCT05071924

Brief Summary

This study aims to examine the implementation and effectiveness of the original version of PLH Teens delivered in-person (PLH Teens-Original) and a hybrid in-person and remote delivery of the programme (PLH Teens-Hybrid) as part of the Mothers2Mothers' (M2M) Children and Adolescents are My Priority (CHAMP) project in Mpumalanga, South Africa. It will also examine differential effects between PLH Teens-Original and PLH Teens-Hybrid on reducing risks of violence against children using propensity score matching. Lastly, it will examine the implementation feasibility of PLH Teens-Hybrid in terms of implementation fidelity; recruitment, retention, and engagement of parents and adolescents; and the relevance, acceptability, and satisfaction of the programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,128

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

September 27, 2021

Last Update Submit

May 7, 2024

Conditions

Keywords

Parenting programmeChild physical and emotional abuse

Outcome Measures

Primary Outcomes (2)

  • Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Parent Report

    Child maltreatment will be assessed using a shortened version of the ISPCAN Child Abuse Screening Tools-Trial Version (9-item subscale ICAST-T). Parent respondents will be asked to indicate the frequency of emotional and physical discipline practices over the past month using a 9-point frequency count scale (0 = never; 8 = 8 or more times). Items include, "In the past 4 weeks, how often did you/your caregiver discipline your child/you by spanking, slapping or hitting with a hand?" and "In the past 4 weeks, how often did you/your caregiver shout, yell or scream at you?" In the past 4 weeks, how often did you/your caregiver discipline your child/you with an object like a stick or a belt?". Items are summed, with higher scores indicating greater use of harsh parenting.

    Change between Baseline and Post (approx. 4 months post-baseline)

  • Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Teen Report

    Child maltreatment will be assessed using a shortened version of the ISPCAN Child Abuse Screening Tools-Trial Version (9-item subscale ICAST-T). Teen respondents will be asked to indicate the frequency of emotional and physical discipline practices over the past month using a 9-point frequency count scale (0 = never; 8 = 8 or more times). Items include, "In the past 4 weeks, how often did you/your caregiver discipline your child/you by spanking, slapping or hitting with a hand?" and "In the past 4 weeks, how often did you/your caregiver shout, yell or scream at you?" In the past 4 weeks, how often did you/your caregiver discipline your child/you with an object like a stick or a belt?". Items are summed, with higher scores indicating greater use of harsh parenting.

    Change between Baseline and Post (approx. 4 months post-baseline)

Secondary Outcomes (16)

  • Parenting Stress: Parenting Stress Scale

    Change between Baseline and Post (approx. 4 months post-baseline)

  • Child Maltreatment - Physical Abuse and Emotional Abuse: ISPCAN Child Abuse Screening Tool-Intervention (ICASTTP) - Physical and Emotional Abuse Subscales

    Change between Baseline and Post (approx. 4 months post-baseline)

  • Positive Parenting: Alabama Parenting Questionnaire - Parent Report

    Change between Baseline and Post (approx. 4 months post-baseline)

  • Positive Parenting: Alabama Parenting Questionnaire - Teen Report

    Change between Baseline and Post (approx. 4 months post-baseline)

  • Child Behaviour Problems: Strengths and Difficulties Questionnaire - Parent Report

    Change between Baseline and Post (approx. 4 months post-baseline)

  • +11 more secondary outcomes

Other Outcomes (7)

  • Demographics: Demographic Survey - Parent Report

    Baseline

  • Demographics: Demographic Survey - Teen Report

    Baseline

  • Enrolment Rates of Participant Engagement: Weekly Facilitator Survey - Facilitator Report

    Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery

  • +4 more other outcomes

Study Arms (2)

PLH Teens Original

EXPERIMENTAL

The original in-person PLH programme is delivered by community-based workers in low-resource settings. Implementation occurs in a group-based format with both joint parent and teen sessions (10 sessions) and separate parent and teen sessions (4 sessions).

Behavioral: PLH Teens Original: In-person PLH programme for parents and teens by community-based workers

PLH Teens Hybrid

EXPERIMENTAL

The hybrid delivery of PLH Teens consists of 8 sessions delivered to parents via WhatsApp (ParentChat-Teens) and 4 sessions delivered to parents and adolescents in person.

Behavioral: PLH Teens Hybrid: Hybrid delivery for parents and teens by facilitators

Interventions

This in-person intervention is delivered over 14 sessions (10 joint parent and teen sessions and 4 separate parent and teen sessions).

PLH Teens Original

The hybrid intervention delivered over 12 sessions (8 sessions delivered via WhatsApp groups to parents only and 4 sessions delivered in-person to parents and teens together).

PLH Teens Hybrid

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any person over the age of 18 currently caring for a child between the ages of 10 and 17
  • Has the ability to attend the in-person parenting support group (PLH Teens-Original)
  • Has access to a WhatsApp compatible smartphone and is willing to join an online parenting support group (PLH Teens-Hybrid)
  • Has provided consent to participate in the study
  • Must be between the age of 10 and 17
  • Has a parent or caregiver who is participating in the programme
  • Parent has provided consent to participate in the study
  • Has provided assent to participate in the study
  • The facilitator must be over the age of 18
  • Has completed a facilitator training workshop specifically for the PLH-Teens hybrid delivery prior to intervention delivery
  • Is able to access the in-person session location
  • Has a smart-phone or device capable of delivering the programme via an online platform such as WhatsApp or Viber
  • Has provided informed consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX1 2ER, United Kingdom

Location

Study Officials

  • Jamie M. Lachman, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a pre-post study with assessments at baseline and immediate post- intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 8, 2021

Study Start

July 5, 2021

Primary Completion

December 31, 2021

Study Completion

June 1, 2022

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Anonymised data will be shared on Open Science Framework after the completion of the study and results are published.

Shared Documents
STUDY PROTOCOL
Time Frame
Indefinitely
Access Criteria
Accessibility of the data will require approval from the study team. The study investigators, led by the PI, will jointly make decisions on whether to supply research data to potential new users. Research data will be deposited in and available in the UK Data Archive solely for non-profit use.

Locations